Article Figures & Data
Figures
- Fig 1.
Randomization scheme in 34 patients randomized in either the percutaneous vertebroplasty (PV) treatment arm (n = 18 patients) or the optimal pain medication (OPM) treatment arm (n = 16 patients). After 2 weeks of treatment, 14 patients treated by OPM requested treatment by PV and 2 patients continued the OPM treatment.
Tables
- Table 1:
Characteristics of the total group of patients and categorized by treatment arm: PV and OPM, before initiating therapy; P value for differences in PV versus OPM
Total PV OPM P Number of patients 34 18 16 Age (years) 73 (55–88) 72 (59–84) 74 (55–88) .4 Female sex (%) 28 (82) 14 (78) 14 (88) .5 Duration of back pain 81 (46–141) 85 (47–138) 76 (46–141) .4 Total number of pre-existing VCF 108 59 48 .5 Mean (range) 3.2 (1–8) 3.3 (1–8) 3.1 (1–8) Distribution of pre-existing VCF T5–L5 T5–L5 T5–L5 .5 Total number of treated VCF 49 28 21 .04 Mean (range) 1.4 (1–3) 1.6 (1–3) 1.2 (1–2) Distribution of treated VCF T6–L5 T6–L5 T6–L5 .5 Shape-treated VCF (%) .02 Wedge 38 (78) 25 (89) 13 (62) Biconcave 11 (22) 3 (11) 8 (38) Grade-treated VCF (%) .1 Mild 6 (12) 3 (11) 3 (14) Moderate 11 (22) 6 (21) 5 (24) Severe 32 (65) 19 (68) 13 (62) Compression of treated VCF (%) 45 (15–72) 47 (23–72) 42 (15–68) .3 Initial VAS for pain 7.3 (5–10) 7.1 (5–9) 7.6 (5–10) .3 Initial pain medication (%) .5 None 3 (9) 2 (11) 1 (6) Paracetamol 11 (32) 4 (22) 7 (44) NSAIDs 9 (27) 6 (33) 3 (19) Opiate derivative 11 (32) 6 (33) 5 (31) QUALEFFO 63 (37–86) 60 (37–86) 67 (38–86) .1 RMD 16.7 (8–24) 15.7 (8–22) 17.8 (9–24) .2 Note:—PV indicates percutaneous vertebroplasty; OPM, optimal pain medication; VCF, vertebral compression fracture; VAS, visual analog scale; NSAID, nonsteroidal anti-inflammatory drug; QUALEFFO, Quality of Life Questionnaire of the European Foundation for Osteoporosis; RMD, Roland-Morris Disability questionnaire. Numbers are mean (range) or absolute number (percentage) if indicated by (%).
- Table 2:
Mean VAS for pain and analgesic use scores before start of treatment and at 1 day after start of the treatment and the mean changes in both scores in 18 patients treated by PV and 16 patients treated by OPM; P value and 95% CI of the differences between patients after PV and patients treated by OPM
PV (n = 18) OPM (n = 16) Difference PV–OPM 95% CI Difference Initial scores VAS for pain (range) 7.1 (5–9) 7.6 (5–10) Analgesic use (range) 1.9 (0–3) 1.7 (0–3) Scores after 1 day VAS for pain (range) 4.7 (1–8) 7.1 (5–10) −2.4 −3.7–−1.0 Change −2.3 −0.5 −1.8 −2.9–−0.8 Analgesic use (range) 1.1 (0–3) 2.5 (1–3) −1.4 −2.1–−0.8 Change −0.8 +0.8 −1.6 −2.3–−0.8 Note:—VAS indicates visual analog scale; PV, percutaneous vertebroplasty; OPM, optimal pain medication; CI, confidence interval.
- Table 3:
Mean VAS for pain and analgesic use scores at 2 weeks after initiation of treatment and the mean changes in scores compared with initial scores and scores 1 day after treatment in 18 patients treated by PV and 16 patients treated by OPM
PV (n = 18) OPM (n = 16) Difference PV–OPM 95% CI Difference Initial scores VAS for pain (range) 7.1 (5–9) 7.6 (5–10) Analgesic use (range) 1.9 (0–3) 1.7 (0–3) QUALEFFO (range) 60 (37–86) 67 (38–86) RMD (range) 15.7 (8–22) 17.8 (9–24) Scores after 2 weeks VAS for pain (range) 4.9 (0–10) 6.4 (3–9) −1.5 −3.2–0.2 Change vs initial score −2.1 −1.1 −1.0 −0.5–2.5 Change vs 1 day +0.2 −0.6 0.8 −2.4–0.7 Analgesic use 1.2 (0–3) 2.6 (2–3) −1.4 −2.0–−0.8 Change vs initial score −0.7 +0.9 −1.5 −2.3–−0.8 Change vs 1 day −0.2 −0.1 −0.1 −0.4–0.5 QUALEFFO (range) 53 (28–79) 67 (40–88) −14 −24.7–−3.4 Change −6.8 −0.7 −6.1 −10.7–−1.6 RMD (range) 13 (3–22) 18 (9–23) −5 −8.4–−1.2 Change (%) +19 −2 21 0.07–0.35 Note:—VAS indicates visual analog scale; PV, percutaneous vertebroplasty; OPM, optimal pain medication; CI, confidence interval; QUALEFFO, Quality of Life Questionnaire of the European Foundation for Osteoporosis; RMD, Roland-Morris Disability questionnaire.
- Table 4:
Mean scores of the subgroups of the QUALEFFO before and 2 weeks after therapy in 18 patients treated by PV and 16 patients treated by OPM; absolute differences and 95% CI of the differences between patients after PV and patients treated by OPM
QUALEFFO PV (n = 18) OPM (n = 16) Difference PV–OPM 95% CI Difference Initial scores Pain 19 21 −2 −3.6–0.4 Function 10 12 −2 −5.3–0.6 Mobility 18 20 −2 −5.9–1.4 Stature 23 27 −4 −9.6–1.5 Social 26 27 −1 −4.7–2.9 Quality of life 11 12 −1 −2.3–0.9 Emotion 31 33 −2 −4.0–0.6 2 Weeks after therapy Pain 14 20 −6 −8.5–−2.5 Function 8 13 −5 −7.5–−2.0 Mobility 16 20 −4 −8.3–−0.3 Stature 21 27 −6 −11.8–−1.0 Social 25 26 −1 −4.6–3.5 Quality of life 11 12 −1 −2.9–0.3 Emotion 31 32 −1 −3.2–1.2 Note:—QUALEFFO, Quality of Life Questionnaire of the European Foundation for Osteoporosis; PV, percutaneous vertebroplasty; OPM, optimal pain medication; CI, confidence interval.
- Table 5:
Mean scores in 14 patients randomized for OPM who requested crossover to treatment by PV 2 weeks after start of the study
OPM Treatment (n = 14) After Crossover to PV (n = 14) Difference OPM–PV 95% CI Difference 1 Day VAS for pain (range) 7.4 (5–10) 3.9 (0–10) −3.5 −4.8–−2.1 Analgesic use (range) 2.5 (1–3) 0.9 (0–3) −1.6 −2.4–−0.9 2 Weeks VAS for pain (range) 6.8 (4–9) 3.3 (0–7) −3.5 −4.9–−2.1 Analgesic use (range) 2.6 (2–3) 0.9 (0–3) −1.7 −2.5–−1.0 QUALEFFO 67 53 14 8.5–19 RMD 18 11 7 2.4–11.4 QUALEFFO subsections Pain 20 13 −7 −10.6–−2.6 Function 13 9 −4 −5.6–−2.5 Mobility 20 16 −4 −6.7–−1.6 Stature 27 22 −5 −8.3–−1.6 Social 26 25 −1 −3.1–−0.1 Quality of life 12 11 −1 −2.1–0.1 Emotion 32 31 −1 −2.3–0.2 Note:—OPM, optimal pain medication; PV, percutaneous vertebroplasty; CI, confidence interval; VAS, visual analog scale; QUALEFFO, Quality of Life Questionnaire of the European Foundation for Osteoporosis; RMD, Roland-Morris Disability questionnaire.
In this issue
Jump to section
Related Articles
Cited By...
- Vertebroplasty for osteoporotic vertebral fracture
- The evidentiary basis of vertebral augmentation: a 2019 update
- The Diagnostic Value of Magnetic Resonance Imaging in Identifying Unsuspected Malignancy in Patients Undergoing Percutaneous Vertebral Augmentation for Vertebral Compression Fractures
- ISASS Policy 2018--Vertebral Augmentation: Coverage Indications, Limitations, and/or Medical Necessity
- Vertebroplasty and Kyphoplasty for Osteoporotic Vertebral Fractures: What Are the Latest Data?
- Percutaneous cement augmentation for osteoporotic vertebral fractures
- Comparing Percutaneous Vertebroplasty and Conservative Therapy for Treating Osteoporotic Compression Fractures in the Thoracic and Lumbar Spine: A Systematic Review and Meta-Analysis
- Critique of the Analysis of UpToDate.com on the Treatment of Painful Vertebral Compression Fractures: Time to Update UpToDate
- Vertebral augmentation: report of the Standards and Guidelines Committee of the Society of NeuroInterventional Surgery
- Impact of Nonoperative Treatment, Vertebroplasty, and Kyphoplasty on Survival and Morbidity After Vertebral Compression Fracture in the Medicare Population
- Percutaneous vertebroplasty for subacute and chronic painful osteoporotic vertebral compression fractures can safely be undertaken in the first year after the onset of symptoms
- Comparative Study of Percutaneous Vertebral Body Perforation and Vertebroplasty for the Treatment of Painful Vertebral Compression Fractures
- Natural History of Pain in Patients with Conservatively Treated Osteoporotic Vertebral Compression Fractures: Results from VERTOS II
- Post-Vertebral Augmentation Back Pain: Evaluation and Management
- Conservative management of patients with an osteoporotic vertebral fracture: A review of the literature
- Treatment of painful osteoporotic vertebral compression fractures: A BRIEF REVIEW OF THE EVIDENCE FOR PERCUTANEOUS VERTEBROPLASTY
- Percutaneous Balloon Kyphoplasty with the Patient under Intravenous Analgesia and Sedation: A Feasibility Study
- Response to "Randomized Vertebroplasty Trials: Bad News or Sham News?"
- Baseline Pain and Disability in the Investigational Vertebroplasty Efficacy and Safety Trial
- Percutaneous vertebroplasty for the treatment of osteoporotic vertebral compression fractures: EVALUATION AFTER 36 MONTHS
- Vertebroplasty for osteoporotic vertebral fracture